BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 RETINAL PRB STRAIGHT

    MDR report key: 11941167 · Received June 4, 2021

    Report

    Report Number
    1216677-2021-00121
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    January 27, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004144
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR: INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 11/14/2017 UNDER WO # (B)(4) AND SHIPPED ON 2/06/18. MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED FOR A TORN OUTER TUBING. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT REQUIRED AN ADJUSTMENT. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. NOTE: HIGH FREEZE FLOWS WILL AFFECT THE UNIT FROM REACHING OPTIMAL TEMPERATURE. THIS UNIT'S SPRING HOUSE ASSEMBLY REQUIRED RE-WORKING INDICATING THE BALL SETTING WAS OFF. THE BALL IS SOLDERED ONTO THE END OF A WIRE (SPRING ASSEMBLY) WHERE BOTH ARE EXPOSED TO THE RUSHING GAS AND MOVED INTO THE PROPER SEATING POSITION IN THE EXITING ORIFICE. CORRECTIVE ACTIONS: THE UNIT WAS REPAIRED/ADJUSTED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "LEAKING HANDLE GETS ICE COLD". 124 N20 RETINAL PRB STRAIGHT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    LEAKING HANDLE GETS ICE COLD. (B)(4) FOUND; HIGH FREZZE FLOW 16.5MM, POOR SEATING. 3. N20 RETINAL PRB STRAIGHT 124. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840217 N20 RETINAL PRB STRAIGHT N20 RETINAL PRB STRAIGHT HQA COOPERSURGICAL, INC. 124 N/A 00888937004144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other